FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (MPLANTABLE COLLAMER LENS)
MDR report key: 1630426
·
Received March 8, 2010
Report
- Report Number
- 2023826-2010-00226
- Event Type
- Injury
- Date Received
- March 8, 2010
- Date of Event
- February 2, 2010
- Report Date
- February 8, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MICL12.1 IMPLANTABLE COLLAMER LENS WAS EXTRACTED DUE TO THE DEVELOPMENT OF A CATARACT AND THE PATIENT LOST SOME VISION. THE SURGEON'S OFFICE CONFIRMED THE PATIENT HAD A CATARACT IN THE OD AND THE ICL WAS EXTRACTED ON (B) (6) 2010. THE CATARACT WAS NOTED ON (B) (6) 2009 AND THE CAUSE WAS NATURAL PROGRESSION VS ICL RUBBING. TYPE - PRESENILE NS ANT CS CAT OD. A CRYSTALEN AT-52 WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (MPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MICL12.1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | CARTRIDGE: MODEL SFC-45FP, LOT # UNK| INJECTOR: MODEL MSI-TF, LOT # UNK| FOAM TIP PLUNGER: MODEL, LOT # UNK |